IQ-AI Limited - Orphan Drug Designation Status

Imaging Biometrics

28/02/2023 15:52

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RNS Number : 3886R  IQ-AI Limited  28 February 2023

IQ-AI Announces Orphan Drug Designation Status

FDA grants orphan status to Gallium Maltolate for treating GBM

IQ-AI Limited, (LSE: IQAI) (OTCQB: IQAIF), is pleased to announce that the
United States Food and Drug Administration (FDA) has granted orphan drug
designation (ODD) status for gallium maltolate (GaM) for the treatment of
glioblastoma multiforme (GBM) brain cancer. GaM is the oral agent under study
in IQAI's sponsored Phase I clinical trial being conducted at the Medical
College of Wisconsin (MCW) in Milwaukee, Wisconsin.

 

ODD status is given to drugs that show promise in treating rare diseases or
conditions that affect fewer than 200,000 people in the United States. These
diseases are typically serious or life threatening. In 1983, the US government
passed the Orphan Drug Act to provide companies with certain benefits for
developing orphan drugs with the goal of accelerating drug development for
these patients.

 

The ODD status is independent of the overall approval process by the FDA.
However, as the clinical trial continues, IQAI intends to take full advantage
of the benefits orphan designation offers including assistance in the drug
development process, tax credits, grant opportunities, and seven years of
market exclusivity post-approval.

 

Enrolment is ongoing in the Phase I clinical trial to evaluate the safety and
tolerability of GaM and to identify the recommended phase 2 dose (RP2D)
necessary for a Phase II clinical trial. A Phase II clinical trial, the next
major developmental step, will be undertaken to officially assess if GaM works
in GBM.

 

"This designation is a critical milestone in the development of GaM. It brings
the possibility of making an oral agent available as a treatment option for
glioblastoma multiforme brain cancer, closer to reality," said Trevor Brown,
CEO of IQ-AI Limited.

 

The Directors of the Company accept responsibility for the contents of this
announcement.

 

-ENDS-

 

For further information, please contact:

 

IQ-AI Limited

Trevor Brown/Brett Skelly/Vinod Kaushal

Tel: 020 7469 0930

 

Peterhouse Capital Limited (Financial Adviser and Broker)

Lucy Williams/Heena Karani

Tel: 020 7220 9797

 

 

About IQ-AI Limited

IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), the parent company of
Wisconsin-based Imaging Biometrics, LLC (IB), is focused on delivering
quantitative imaging platforms and therapeutics that transform how clinicians
diagnose and treat patients more efficiently and effectively. For more
information about Imaging Biometrics, visit the company's website at
www.imagingbiometrics.com (http://www.imagingbiometrics.com)

 

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